03037nas a2200505   4500000000100000008004100001653003200042653002800074653001000102653002800112653001700140653001900157653001500176653001100191653001100202653002000213653002900233653001500262653001200277653001500289653001400304653002200318653003100340653002400371100001800395700001500413700001600428700001600444700001300460700001600473700001600489700001500505700001800520700001200538700001800550700001500568700001300583700001700596700001200613245013300625300001100758490000700769520174100776022001402517       2000                            d10aAbnormalities, Drug-Induced10aAdrenal Cortex Hormones10aAdult10aChi-Square Distribution10aCleft Palate10aCohort Studies10aCounseling10aFemale10aHumans10aInfant, Newborn10aMaternal Health Services10aOdds Ratio10aOntario10aPrednisone10aPregnancy10aPregnancy Outcome10aPregnancy Trimester, First10aProspective Studies1 aPark-Wyllie L1 aMazzotta P1 aPastuszak A1 aMoretti M E1 aBeique L1 aHunnisett L1 aFriesen M H1 aJacobson S1 aKasapinovic S1 aChang D1 aDiav-Citrin O1 aChitayat D1 aNulman I1 aEinarson T R1 aKoren G00aBirth defects after maternal exposure to corticosteroids: prospective cohort study and meta-analysis of epidemiological studies.  a385-920 v623 a<p><strong>BACKGROUND: </strong>Corticosteroids are first-line drugs for the treatment of a variety of conditions in women of childbearing age. Information regarding human pregnancy outcome with corticosteroids is limited.</p>

<p><strong>METHODS: </strong>We collected prospectively and followed up 184 women exposed to prednisone in pregnancy and 188 pregnant women who were counseled by Motherisk for nonteratogenic exposure. The primary outcome was the rate of major birth defects. A meta-analysis of all epidemiological studies was conducted. The Mantel-Haenszel summary odds ratio was calculated for the pooled studies with 95% confidence intervals. A cumulative summary odds ratio was also calculated by combining studies in chronological order. Chi-squared for homogeneity was determined to establish the comparability of the studies.</p>

<p><strong>RESULTS: </strong>In our prospective study, there was no statistical difference in the rate of major anomalies between the corticosteroid-exposed and control groups. In the meta-analysis, the Mantel-Haenszel summary odds ratio for major malformations with all cohort studies was 1.45 [95% CI 0.80, 2.60] and 3.03 [95% CI 1.08, 8. 54] when Heinonen et al. ('77) was removed. This suggests a marginally increased risk of major malformations after first-trimester exposure to corticosteroids. In addition, summary odds ratio for case-control studies examining oral clefts was significant (3.35 [95% CI 1.97, 5.69]).</p>

<p><strong>CONCLUSIONS: </strong>Although prednisone does not represent a major teratogenic risk in humans at therapeutic doses, it does increase by an order of 3.4-fold the risk of oral cleft, which is consistent with the existing animal studies.</p>
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